The new memos from the Food and Drug Administration show how the agency’s vaccine chief, Dr. Vinay Prasad, personally intervened to place restrictions on COVID shots from vaccine makers Novavax and ...

Moderna, Inc. (MRNA) on Thursday announced that the U.S. Food and Drug Administration (FDA) has fully approved its COVID-19 vaccine Spikevax in children aged six months through 11 years who are at ...

INDICATION mNEXSPIKE is a vaccine to protect against COVID-19. mNEXSPIKE is for people who have received a COVID-19 vaccine before and are: • 65 years of age and older, or • 12 years through 64 years ...

mNEXSPIKE becomes Moderna's third FDA-approved product CAMBRIDGE, MA / ACCESS Newswire / May 31, 2025 / Moderna, Inc. (NASDAQ:MRNA) today announced that the U.S. Food and Drug Administration (FDA ...

Moderna expects to have mNEXSPIKE available for eligible populations in the U.S. for the 2025-2026 respiratory virus season, alongside Spikevax and mRESVIA ®, the Company's approved respiratory ...

The FDA's approval of mNEXSPIKE is based on results from a randomized, observer-blind, active-controlled Phase 3 clinical trial (ClinicalTrials.gov Identifier: NCT05815498), which enrolled ...